FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
10884389148563
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
NON29858
Catalog number
NON29858
Device description
COVER,SHOE,MLTILAYER,STRIPEN-SKD,BLU,REG
Published
2021-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BWPSHOE AND SHOE COVER, CONDUCTIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWPShoe And Shoe Cover, ConductiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40884389148564PackageGS1300In Commercial Distribution
30884389148567PrimaryGS10
10884389148563Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088438914856440884389148564
3088438914856730884389148567
1088438914856310884389148563

GMDN Terms#

Term, Definition table
TermDefinition
Shoe coverA loose fabric covering intended to be placed over a shoe to create a physical barrier to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the shoe and the environment, or a patient and staff. It is typically used in areas such as examination rooms or operating theatres and may be conductive, to reduce the risk of static electricity, or non-conductive. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10840330706596ProCureTwin Med, LLCBWP2026-05-05
00688162000665ProtexerICP MEDICAL, LLCBWP2026-04-27
00688162000672ProtexerICP MEDICAL, LLCBWP2026-04-27
10817583020342Critical CoverAlpha Pro Tech, Inc.BWP2026-04-16
00688162000023ProtexerICP MEDICAL, LLCBWP2025-08-19
00813360021789ProtexerICP MEDICAL, LLCBWP2025-08-19
00813360021796ProtexerICP MEDICAL, LLCBWP2025-08-19
10688162000020ProtexerICP MEDICAL, LLCBWP2025-08-19
10813360021786ProtexerICP MEDICAL, LLCBWP2025-08-19
10813360021793ProtexerICP MEDICAL, LLCBWP2025-08-19
00810184641032GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641049GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641056GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641063GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641070GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641087GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642589GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642596GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641407GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641414GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641421GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641438GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641445GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184641452GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642763GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00810184642770GCB Medical SupplyGCB MEDICAL LLCBWP2025-07-24
00850061859037GCB Medical Supply NovaplusGCB MEDICAL LLCBWP2025-07-23
00850061859136GCB Medical Supply NovaplusGCB MEDICAL LLCBWP2025-07-23
TQ26126151041Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.BWP2024-12-09
TQ26126151040Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.BWP2024-12-09